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Sinew Acupuncture for Knee Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03099317
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
The University of Hong Kong

Brief Summary:
The study aims to exam whether sinew acupuncture can relieve pain and symptoms of KOA and improve functional movement by Visual Analog Scale (VAS), Western Ontario and McMasters University Osteoarthritis Index (WOMAC), Timed up & Go Test (TUG) and 8-step Stair Climb Test (SCT) assessment, and Quality of life by Short Form-36 (SF-36). A randomized, sham acupuncture controlled, patient and assessor blinded, pilot study will be employed.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Other: Sinew acupuncture Other: Sham acupuncture Not Applicable

Detailed Description:

Objective:

The proposal aims to examine the efficacy and safety of sinew acupuncture for knee osteoarthritis (KOA).

Hypothesis to be tested:

Sinew acupuncture can reduce pain intensity, and improve knee function and health-related quality of life without significant side effects for KOA subjects compared to a sham acupuncture.

Design:

A randomized, subject- and assessor-blind, sham acupuncture-controlled clinical trial

Participants:

Subjects (N=86) will be randomized into sinew acupuncture or sham acupuncture group (in 1:1 ratio).

Study instrument:

Visual Analog Scale (VAS), Western Ontario and McMasters University Osteoarthritis Index (WOMAC), Timed up & Go Test (TUG), 8-step Stair Climb Test (SCT) assessment, and the Short Form-36 (SF-36).

Intervention:

Sinew acupuncture group will receive 10 sessions of needling in 4 weeks. Sham group will receive the non-invasive intervention with the same procedures. All subjects are followed up for 6 weeks.

Main outcome measures:

VAS for knee pain intensity at week 4 serves as the primary outcome. VAS at other time points, WOMAC score, TUG, SCT and SF-36 will be analyzed as the secondary outcomes.

Data analysis:

Analysis will be on the 'intention to treat' principle. T-test and mixed-effect model analysis will be used to measure primary and secondary outcomes respectively.

Expected results:

Sinew acupuncture treatment can significantly reduce knee pain intensity, and improve knee function and quality of life without obvious side effects.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized sham controlled, single blinded trial
Masking: Double (Participant, Outcomes Assessor)
Masking Description:

Participants will be randomized into sinew acupuncture group and sham acupuncture group in a 1:1 ratio.

Assessors will perform the assessment but not be involved in acupuncture treatment.

Primary Purpose: Treatment
Official Title: Sinew Acupuncture for Knee Osteoarthritis (KOA): A Randomized, Sham Controlled, Patient and Assessor Blinded, Pilot Trial
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : September 30, 2018
Actual Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sinew acupuncture
Subject in the arm will receive real acupuncture intervention.
Other: Sinew acupuncture
Sinew acupuncture: subject will sit on chair with knee joint flexion with a most comfortable angle nearest to 90 degrees. Acupoints (1-2cm away from the point of tenderness or pain) near the knee will be punctured through the skin by using sterile needles of size 0.30mm × 40mm at the angle of 0-10 degrees pointing along the pain direction and meridian sinew. Immediately, needles will be retreated back just under the skin and inserted 10mm-20mm forward smoothly with minimal pain sensation. Walking and stepping will be advised and governed during acupuncture. The acupoint will be covered with non-allergic bandages to ensure sufficient blinding to the subject. The treatment will last 20 minutes for each session.

Sham Comparator: Sham acupuncture
Subject in the arm will receive sham acupuncture intervention.
Other: Sham acupuncture
Sham acupuncture: subject will receive the same procedures as the sinew acupuncture without penetrating the skin. The needle will be used to puncture on the acupoint slightly without passing through the skin. The acupoint will be covered with non-allergic bandages to ensure sufficient blinding to the subject.




Primary Outcome Measures :
  1. Pain intensity measured by VAS [ Time Frame: Week 4 ]
    Pain intensity will be measured by VAS


Secondary Outcome Measures :
  1. WOMAC [ Time Frame: Weeks 0, 1, 2, 3, 4, 6 and 10 ]
    Western Ontario and McMasters University Osteoarthritis Index

  2. TUG [ Time Frame: Weeks 0, 2, 4, 6 and 10 ]
    Timed up and go test

  3. 8-step SCT [ Time Frame: Weeks 0, 2, 4, 6 and 10 ]
    Stair Climb Test

  4. Quality of life measured by SF-36 [ Time Frame: Weeks 0, 4, and 10 ]
    Short Form-36



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hong Kong permanent residents aged on or above 50, both male and female;
  • meet the Clinical Classification Criteria for Osteoarthritis of the Knee by history, physical examination and radiographic findings (recommended by the American College of Rheumatology): history and physical examination: pain in the knee and one of the following (1. Over 50 years of age; 2. Less than 30 minutes of morning stiffness; 3. Crepitus on active motion and osteophytes) and radio graphical findings (Kellgren and Lawrence Grades 2-4):
  • with unilateral knee pain or bilateral knee pain;
  • in chronic stage (pain of at least 6 month's duration);
  • with rated knee pain >40 mm on a visual analog scale (VAS; 0 to 100 mm) within 7 days;
  • with X-ray or other radiographic reports are preferable (not necessary);
  • who volunteer to participate and sign the consent form;
  • able to write and read Chinese.

Exclusion Criteria:

  • Patients who are unable to walk;
  • with serious infection of knee;
  • with suspected tears of ligaments, menisci or acute inflammation of synovial capsule;
  • with trauma, ligament damage, fracture, or surgery on the knee(s) within 6 months, as the cause of pain or functional problems (history of knee replacement will be excluded);
  • with history of local tumor/malignancy at knee;
  • with physical or laboratory findings indicating infection, presence of autoimmune disease or inflammatory arthritis;
  • with knee pain caused by radiculopathy / herniation of intervertebral disc;
  • with end-stage of diseases and other suspected severe conditions such as deep vein thrombosis of the lower limb, edema related to cancer or cancer treatment, severe blood coagulation disorders, uncontrolled systemic arterial hypertension and severe diabetes;
  • with history of prolotherapy, with injections of hyaluronic acid or cortisone within 3 months;
  • received acupuncture, electro-acupuncture, Tui-na therapy, massage, physiotherapy for 8 weeks prior to the trial;
  • with more severe pain in other regions;
  • have severe mental disorders;
  • oversensitive to needles;
  • insensitive to pain due to advanced diabetes, neuropathy or using strong painkillers;
  • fail to be complaint with the treatment protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03099317


Locations
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Hong Kong
The Hong Kong Tuberculosis, Association The University of Hong Kong Clinical Centre for Teaching and Research in Chinese Medicine (Wan Chai)
Wan Chai, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Haiyong Chen, PhD The University of Hong Kong
Principal Investigator: Kwok Yin Au, PhD The Hong Kong Tuberculosis Association Chinese Medicine Clinic cum Training Centre of the University of Hong Kong
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03099317    
Other Study ID Numbers: UHongKong-UW16-2007
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The University of Hong Kong:
Knee Osteoarthritis
Sinew Acupuncture
Pain
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases